Our Mission
Our mission is to develop therapeutic solutions targeting rare and life-threatening liver diseases with high unmet medical needs. Being a pioneer in the indications we target, we identify high-potential assets and capitalize on our scientific, clinical and regulatory expertise to bring them from early development stages to pre-commercial readiness.
Rare Diseases
Rare diseases are medical conditions that affect a relatively small number of people in a population: in the US, a disease is classified as rare when it affects less than 200,000 individuals1, whilst in Europe, the definition of a rare disease corresponds to <5 in 10,000 people2 . Today, there are about 7,000 rare diseases worldwide3 , with more than 300 million patients4 concerned. 95%4 of these diseases do not have an approved treatment.
Life-Threatening Diseases
Diseases are considered as life-threatening when they exhibit significant impact on an individual’s health and wellbeing and are associated with high mortality in a near-term. They typically involve a high degree of intensity, seriousness, or acuteness in terms of symptoms, progression, or complications. Life-threatening diseases often result in substantial impairment of bodily functions, substantial pain or discomfort, and a diminished quality of life for those affected.
High Unmet Medical Needs
Unmet needs arise when there is a significant gap between the existing therapies or interventions available and the level of care required to effectively manage or treat a condition. Several factors contribute to the classification of a high unmet medical need: lack of effective treatments, limited treatment options, and severity of the condition in a given patient population.
Our History
Positive 52-week results from Phase 3 ELATIVE® trial of elafibranor in patients with Primary Biliary Cholangitis (PBC), a rare cholestatic liver disease
Completion of the acquisition of Versantis AG, a Swiss-based clinical stage biotech company
Exclusive licensing agreement with Ipsen for elafibranor, a Phase III asset evaluated in PBC, as part of a long-term global partnership
Results from interim analysis of RESOLVE-IT® Phase 3 trial of elafibranor in adults with NASH and fibrosis
Listing of GENFIT and its American Depositary Shares on the Nasdaq Global Select Market in the United States under the symbol “GNFT”
Listing of GENFIT on the Alternext Market of Euronext Paris and transferred in 2014 onto the Euronext Market in Paris (compartment B – ISIN: FR0004163111)
Creation of GENFIT CORP., our subsidiary in Cambridge (Massachusetts, USA)
Development of Research & Development know-how via collaborations with Big Pharma5
Founding by Jean-François Mouney, now Chairman of the Board of Directors
Partnerships & Collaborations
Throughout our history, we have had R&D programs that we have out-licensed, such as our late-stage therapeutic elafibranor program (to Ipsen) and our late-stage NASH diagnostic program (to Labcorp). We also acquired the rights of innovative assets via in-licensing agreements. Today, we have long- term collaborations with:
Ethics & Transparency
As the foundation of our relationships, ethics and transparency are at the heart of everything we do. We adhere to a specific code of clear guidelines that ensure our interactions with stakeholders are grounded in trust. As a matter of policy, we promote a high standard of integrity by conducting our affairs in an honest and ethical manner.
Employees and external stakeholders can report behavior that is contrary to the law or to the principles of our Code of Business Conduct & Ethics through a secure whistleblower platform provided for this purpose is accessible at the following URL address: https://genfit.alertcenter-ikarian.eu/. Concerns may also be reported by post to the attention of the Chief Compliance Officer at: GENFIT – Parc Eurasanté, 885, Avenue Eugène Avinée, 59 120 Loos, France.
We operate with Loyalty & Ethics
We foster a culture of accountability, and we believe that our commitment to the highest level of ethical conduct should be reflected in all of the Company’s business activities. All employees, officers, and directors must act in accordance with the language and spirit of GENFIT’s Code of Ethics: representing the corporate ethos in all aspects of life, exercising reasonable judgment when conducting business, and following appropriate behavioral norms.
We rely on Trusted Subcontractors
We rely on trusted subcontractors to support a significant portion of our business activities, particularly those requiring specific regulatory approvals, such as Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP).
1 US Food and Drug Administration. Rare Diseases: Natural History Studies for Drug Development: Draft Guidance for Industry. 2019. Accessed March 4, 2022 – https://www.fda.gov/media/122425/download
2 Regulation (EC) No 141/2000 – https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32000R0141
3 National organization for Rare Disorders, RDD FAQ 2019
4 Nguengang Wakap S. et al., Eur J Hum Genet 28, 165–173 (2020)
5 Such as Sanofi, Aventis, Merck, UCB Pharma, Solvay/Abbott, Pierre Fabre, Kowa